Urinary incontinence device

ABSTRACT

A urinary incontinence device for alleviating female urinary incontinence is disclosed. The device includes a resilient member and a non-absorbent positioned adjacent to the resilient member. The non-absorbent is constructed from a fibrous material. The resilient member and the non-absorbent are rolled into a softwind having a first end, a second end, a first end diameter and a second end diameter. The resilient member is located adjacent to the second end of the softwind such that the second end diameter is larger than the first end diameter. The softwind is radially compressed into a pledget having an initial diameter, an insertion end, a trailing end and a uniform cross-sectional area therebetween. The insertion end is capable of expanding radially outward about 1.2 to about 10 times the initial diameter and the resilient member is capable of providing a supportive backdrop for a woman&#39;s urethra when inserted into a woman&#39;s vagina.

FIELD OF THE INVENTION

This invention relates to a urinary incontinence device for alleviatingfemale urinary incontinence and a method of making the same. Morespecifically, this invention relates to a urinary incontinence devicefor alleviating female urinary incontinence during episodes of increasedintra-abdominal pressure.

BACKGROUND OF THE INVENTION

The primary etiological factor producing genuine stress urinaryincontinence is the incomplete transmission of abdominal pressure to theproximal urethra due to displacement from its intra-abdominal position.Some women, especially women who have given birth to one or morechildren, and older women, can experience incidences of involuntaryurine loss due to stress urinary incontinence or combined stress andurge incontinence. A sneeze or cough can increase the intra-abdominalpressure impinging on a person's bladder and cause the involuntaryrelease of urine. The frequency and severity of such urine loss canincrease as the muscles and tissues near the urethro-vaginal myofascialarea grow weaker. It has also been recognized that the urinary sphinctermuscle, which is located at the upper end of the urethra, adjacent tothe bladder, works well at sealing off the passing of urine from thebladder to the urethra when it has a round or circular cross-sectionalconfiguration. Support of the proximal urethra elevates it above thepelvic floor and subjects it to increases in intra-abdominal pressure,thus allowing compression and maintenance of continence. However, whenthis passageway becomes distorted into a cross-sectional configurationhaving more of an elliptical or oval appearance, the sphincter musclecan not close properly, therefore, the tendency for involuntary urineloss increases. One must remember that the urethra and vagina are notseparate structures. Because of their common derivation from theurogenital sinus, they are fused in the distal two thirds of theurethra. In this region, they are bound together by the endopelvicconnective tissue so that the support of the urethra depends not only onthe attachments of the urethra itself to adjacent structures but also onthe connection of the vagina and periurethral tissues to the pelvicwall.

As the world's female population ages, there is an ever-increasing needfor a non-surgical method or measure to reduce the involuntary urineloss commonly associated with stress urinary incontinence. Today, thereare a number of specialized products available for this purpose. Most ofthese products can only be purchased with a prescription and they needto be properly sized, physically inserted and/or adjusted by a medicaldoctor or a nurse practitioner in order for them to perform correctly.Few, if any, products are commercially available in the United States,without a prescription, to prevent involuntary urine loss from stressurinary incontinence.

In view of the lack of commercially available, non-prescription urinaryincontinence prevention or mitigation devices, it is recognized thatthere is a need for a urinary incontinence device that can be purchasedwithout a prescription. There is also a need for a urinary incontinencedevice that is uncomplicated and therefore more user friendly and can bemanaged by the consumer without the intervention of a medicalpractitioner. Furthermore, there is a need for a urinary incontinencedevice which is easy for women to insert into and remove from theirbodies, be more comfortable to wear and provide psychological andrealistic assurance that it is capable of properly performing over anextended period of time.

SUMMARY OF THE INVENTION

Briefly, this invention relates to a urinary incontinence device foralleviating female urinary incontinence. The urinary incontinence deviceincludes a resilient member and a non-absorbent positioned adjacent tothe resilient member. The non-absorbent is constructed from a fibrousmaterial wherein the fibers do not absorb significant quantities ofmoisture within the fibers. The resilient member and the non-absorbentare rolled into an elongated softwind with the resilient member locatedadjacent to an end thereof. The softwind has a larger diameter at oneend. The softwind is then radially compressed into an elongated pledgethaving an insertion end, a trailing end and a uniform cross-sectionalarea therebetween. The resilient member is capable of expanding theinsertion end of the pledget to provide a supportive backdrop for awoman's urethra when inserted into a woman's vagina.

The general object of this invention is to provide a urinaryincontinence device for alleviating female urinary incontinence. Morespecifically, this invention relates to a urinary incontinence devicefor alleviating female urinary incontinence during episodes of increasedintra-abdominal pressure.

A more specific object of this invention is to provide a urinaryincontinence device that is placed in a woman's vagina and providessupport to a woman's urethra to prevent involuntary urine loss commonlyassociated with stress urinary incontinence.

Another object of this invention is to provide a urinary incontinencedevice that is simple to use, easy to insert and remove, and which iscomfortable to wear.

A further object of this invention is to provide a urinary incontinencedevice that can be manufactured and sold for a reasonable cost.

Still another object of this invention is to provide a urinaryincontinence device that can be purchased by a consumer without aprescription.

Still further, an object of this invention is to provide a urinaryincontinence device that does not disrupt the availability of normalvaginal secretions, which are necessary for a healthy vaginalenvironment.

Other objects and advantages of the present invention will become moreapparent to those skilled in the art in view of the followingdescription and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a mid-sagittal section of a human torso showing a urinaryincontinence device positioned in the vaginal canal and cooperating withthe symphysis pubis to allow the urethral tube to be compressed uponitself and alleviate urinary incontinence during episodes of increasedintra-abdominal pressure.

FIG. 2 is a sectional view taken along line 2—2 of FIG. 1 when theinsertion end of the urinary incontinence device is in an expandedcondition closing off the cross-section of the vaginal canal andproviding a supportive backdrop for closing off the urethra.

FIG. 3 is a perspective view of a cover, a non-absorbent and a resilientmember shown in a flat orientation before being rolled and compressed toform a urinary incontinence device.

FIG. 4 is a perspective view of the three layers depicted in FIG. 3after being rolled up along the longitudinal axis X—X to form anelongated softwind having an enlarged end.

FIG. 5 is a perspective view of an elongated pledget having an insertionend, a trailing end and a uniform cross-sectional area therebetween thatis formed by compressing the softwind shown in FIG. 4.

FIG. 6 is a side view of the pledget housed in an applicator.

FIG. 7 is a perspective view of an alternative embodiment of a cover, anon-absorbent and a relatively short resilient member shown in a flatorientation before being rolled and compressed to form a urinaryincontinence device.

FIG. 8 is a perspective view of the three layers depicted in FIG. 7after being rolled up along the longitudinal axis X—X to form anelongated softwind having an enlarged end.

FIG. 9 is a perspective view of an elongated pledget having an insertionend, a trailing end and a uniform cross-sectional area therebetween thatis formed by compressing the softwind shown in FIG. 8.

FIG. 10 is a flow diagram of a method of forming a urinary incontinencedevice.

FIG. 11 is a flow diagram of an alternative method of forming a urinaryincontinence with a cover and housing the device in an applicator.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1 and 2, a human torso 10 of a female is depictedshowing the vagina 12, a cervix 14, a uterus 16, a urethra 18, a bladder20 and a symphysis pubis 22. The vagina 12 has an introital opening 24which exits the human body 10 and contains a vaginal canal 26 whichextends from the introital opening 24 to the cervix 14. The vaginalcanal 26 has a length which ranges from between about 4 inches to about6 inches (about 102 millimeters (mm) to about 153 mm) in most woman. Thecervix 14 is the entrance to the womb and is located between the upperaspect of the vaginal canal 26 and the uterus 16. A rectum 27 is locatedposterior to the vagina 12. The vaginal canal 26 has an inner periphery28. The inner periphery 28 is made up of right and left lateral walls,30 and 32 respectively, an anterior wall 34 and a posterior wall 36, seeFIG. 2. The four walls 30, 32, 34 and 36 encompass the entire 360degrees of the inner periphery 28. The anterior wall 34 is locatedclosest to the urethra 18 and the urethra 18 is located between thesymphysis pubis 22 and the vagina 12. The vaginal canal 26 can bedivided into three approximately equal sections, each representing athird of the overall length. Each section is approximately 2 inches(approximately 51 mm) in length. The middle third of the vaginal canal26 is the most important section for alleviating female urinaryincontinence because of its proximity to the urethra 18 and is thelocation where a urinary incontinence device should be positioned. Themiddle third of the vaginal canal 26 also is horizontally offset fromthe symphysis pubis 22, which is a bony prominence situated adjacent toa front portion 38 of the human torso 10. Cooperation between a urinaryincontinence device positioned in the middle third of the vagina 12 andthe symphysis pubis 22 allows the urethra 18 to be compressed uponitself thereby alleviating involuntary urine flow from the bladder 20.

The urethra 18, also referred to as a urethral tube, is a hollow tubewhich extends from a first opening 40, which exits the human body 10, toa second opening 42 situated at the lower surface of the bladder 20. Theurethra 18 has a length of about 1.5 inches (about 38 mm) in most women.The urethral 8 functions to discharge urine, which is temporarily storedin the bladder 20, from the human body. The urethra 18 has a pluralityof urethral sphincter muscles 44 located along the length of its innerperiphery. The urethral sphincter muscles 44 are situated below theopening 42 and are ringlike muscles that normally maintains constrictionof the urethra 18 to prevent the passage of urine therethrough. Therelaxation of the urethral sphincter muscles 44 by normal physiologicalfunctioning will permit urine to be voluntarily expelled from the humanbody.

Still referring to FIG. 1, the human torso 10 further includesmusculature and body tissue located in the urethro-vaginal myofascialarea 46 which is situated between the vagina 12 and the symphysis pubis22. The bladder 20 lies posterior to the symphysis pubis 22 and isseparated from the rectum 27 by the vagina 12 and the uterus 16. Theureters (not shown), which transport urine from the kidneys to thebladder 20, pass from the pelvis to the posterior aspect of the urinarybladder 20. The fundus vesicae 48, into which both of the uretersterminate, is located adjacent to the anterior wall 34 of the vagina 12.

Referring to FIGS. 1-2, a urinary incontinence device 50 is shownpositioned in the middle third of the length of the vaginal canal 26.The urinary incontinence device 50 is designed to bridge across thevagina 12 and supports the musculature and body tissue located in theurethro-vaginal myofascial area 46. In FIG. 2, the urinary incontinencedevice 50 is shown in an expanded state wherein the resilient portion ofthe urinary incontinence device 50 has expanded outward toward itsoriginal shape. In the expanded state, the insertion end of the urinaryincontinence device 50 has a greater diameter and occupies an overalllarger cross-sectional area than the narrow end. The insertion end ofthe urinary incontinence device 50 extends radially outward and is inintimate contacts with the entire inner periphery of the vaginal canal26. In other words, a portion of the urinary incontinence device 50 isdirectly touching all four interior walls 30, 32, 34 and 36 of thevaginal canal 26 and is providing a supportive backdrop for the urethraltube 18. The urethral tube 18 is now compressed sufficiently tointercept the flow of urine and thereby provides support to the urinarysphincter muscle 44 so that it can function properly. By permitting theurethral tube 18 to be compressed upon itself between the urinaryincontinence device 50 and the symphysis pubis 22, one can limit theinvoluntary flow of urine from the bladder 20.

Referring now to FIGS. 3-5, the urinary incontinence device 50 includesa resilient member 52 and a non-absorbent 54. The resilient member 52can be a natural or synthetic material that has the ability to quicklyrecover or return to approximately its original shape and/or dimensiononce it is placed into a woman's vagina 12. While residing within awoman's vagina 12, the resilient member 52 can contract temporarily bychanges in the intra-abdominal pressure as a result of laughing,sneezing, coughing, or the like. A resilient material is a material thatcan return to or resume its original shape or position after being bent,stretched or compressed. The resilient member 52 should also exhibitelasticity and flexibility so that it can be stretched or compressed andstill retain the capability of returning to approximately its originalshape.

Two natural materials from which the resilient member 52 can be formedinclude natural rubber and wool. The number of synthetic materials fromwhich the resilient member 52 can be formed is much greater. Syntheticmaterials that can be used include polyolefins, polyurethanes,polyethylene oxide (PEO), polyvinyl alcohol (PVA), as well as blendsthereof. The resilient member 52 can also be formed from resilientfibers constructed from polyolefin-based fibers, polyethylene oxidefibers, hydrophobic rayon fibers and the like. Such fibers shouldpreferably have characteristics similar to those of resilient foams. Theresilient fibers can be formed from twisted, curled or cross-linkedcellulose fibers or from a mixture thereof. Furthermore, the resilientmember 52 can be formed from a resilient foam. The resilient foam can bean open cell or a closed cell foam.

The resilient member 52 can also be made from a wettable foam. An opencell wettable foam that works well and has good resilient properties iscommercially available under the trademark ACQUELL®. “ACQUELL” is soldby Sentinel Products Corporation, which has an office at 70 AirportRoad, Hyannis, Mass. 02601. A polyethylene closed cell wettable foamhaving good flexibility characteristics also works well. This foam iscommercially sold under the trademark VOLARA®. “VOLARA” is availablefrom Voltex, a Division of Sekisui America Corporation, having an officeat 100 Shepard Street, Lawrence, Mass. 01843.

The resilient member 52 should also be capable of having what is knownas “dry and wet” expansion characteristics. In other words, theresilient member 52 should be made from a material that is capable ofexpanding or contracting back to or towards its original configurationin a dry state, a wet state or in a semi dry-wet state. Dry expansion ofthe urinary incontinence device 50 is beneficial in that the device doesnot have to be wetted by body fluids before the resilient member 52 iscapable of expanding within a woman's vagina 12.

In FIG. 3, the resilient member 52 is depicted as a relatively longnarrow strip of material being rectangular in cross-section. However,the resilient member 52 can have a square, circular, oval or any othercross-sectional configuration, if desired. The resilient member 52 isshown having a length L₁, a width W₁ and a thickness T₁ The width W₁ andthe thickness T₁ can remain constant over the entire length L₁. Ifdesired, the dimensions of the resilient member 52 can vary so that theresilient member 52 has a non-uniform cross-section along its length L₁.The length L₁ of the resilient member 52 can be equal to or less thanthe length of the non-absorbent 54.

In the embodiment shown in FIG. 3, the length L₁ of the resilient member52 can range from between about 3 inches (about 76 mm) to about 8 inches(about 203 mm). Preferably, the length L₁ of the resilient member 52will be from between about 4 inches (about 102 mm) to about 6 inches(about 152 mm). Most preferably, the length L₁ of the resilient member52 will be about 5 inches (about 127 mm). The width W₁ of the resilientmember 52 can range from between about 0.12 inches (about 3 mm) to about1 inch (about 25 mm). Preferably, the width W₁ of the resilient member52 will be from between about 0.25 inches (about 6.4 mm) to about 0.5inches (about 12.7 mm). Most preferably, the width W₁ of the resilientmember 52 will be about 0.375 inches (about 9.5 mm). The thickness T₁ ofthe resilient member 52 can range from between about 0.1 inch (about 2.5mm) to about 0.5 inches (about 12.7 mm). Preferably, the thickness T₁ ofthe resilient member 52 will be from between about 0.1 inches (about 2.5mm) to about 0.4 inches (about 10 mm). Most preferably, the thickness T₁of the resilient member 52 will be less than about 0.3 inches (about 7.6mm).

When the resilient member 52 has a round or circular cross-sectionalconfiguration, the diameter can range from between about 0.1 inch (about2.5 mm) to about 1.125 inches (about 27.5 mm). Preferably, the diameterof the resilient member 52 will be from about 0.1 inch (about 2.5 mm) toabout 0.5 inches (about 12.7 mm). Most preferably, the diameter of theresilient member 52 will be less than about 0.3 inches (about 7.6 mm).For odd cross-sectional shapes, like an oval, a bi-lobal, a tri-lobal,an ellipse, etc. the larger dimension should be no greater than about1.125 inch (about 27.5 mm).

Referring again to FIG. 3., the non-absorbent 54 is shown having a firstsurface 56, a second surface 58, a first end 60, a second end 62, afirst side edge 64 and a second side edge 66. The non-absorbent 54 alsohas a central longitudinal central axis x—x and a central transverseaxis y—y. The resilient member 52 is positioned adjacent to the firstsurface 56 of the non-absorbent 54. Preferably, resilient member 52 ispositioned parallel to and spaced away from the central longitudinalaxis x—x. As depicted in FIG. 3, the resilient member 52 has alongitudinal side edge 68 and is positioned on the first surface 56 suchthat its side edge 68 is aligned coterminuous with the first side edge64 of the non-absorbent 54. This arrangement allows the resilient member52 to be located approximate one end of the finished urinaryincontinence device 50.

The non-absorbent 54 has a length L₂ that is equal to or greater thanthe length L₁ of the resilient member 52. In addition, the non-absorbent54 has a width W₂ that ranges from between about one to about eighttimes the width W₁ of the resilient member 52. Preferably, the width W₂of the non-absorbent 54 will be from between about two to about fourtimes the width W₁ of the resilient member 52. Most preferably, thewidth W₂ of the non-absorbent 54 is about three times the width W₁ ofthe resilient member 52. The non-absorbent 54 has a thickness T₂ thatcan be less than, equal to or be greater than the thickness T₁ of theresilient member 52. It should be noted that the non-absorbent 54 can bea single ply of material or it can be constructed of two or more plies,such as a laminate.

The non-absorbent 54 is constructed from materials that exhibit little,and preferably no, absorbent characteristics. The non-absorbent 54differs from a catamenial tampon in that it does not function to absorbbody fluid. Instead, the non-absorbent 54 is designed to bridge acrossthe vagina 12 and support the musculature and body tissue located in theurethro-vaginal myofascial area 46. The urethra 18 can be compressedupon itself sufficiently to interrupt the flow of urine and doing so canprovide support to the urinary sphincter muscles 44 so that they canfunction properly.

For purposes of this invention, a non-absorbent is defined as a materialwherein the fibers do not absorb significant quantities of moisturewithin the fibers themselves. It is to be recognized that virtually allmaterials will absorb some small quantity of moisture. A fiber isconsidered to be non-absorbent for present purposes if it willintrinsically gain no more than about 6 percent in weight when abone-dry fiber is maintained at 21 degrees Celsius and at 65 percentrelative humidity for 24 hours. Non-absorbent materials include but arenot limited to nylons, rayons, spun cellulose, LYCRA®), KEVLAR®, carbonfibers and the like. “LYCRA” and “KELVAR” are trademarks of E. I. DuPontde Nemours & Company having an office at 1007 Market Street, Wilmington,Del. 19801. The non-absorbent 54 can also be formed from a web made frombicomponent fibers which are commercially available from ChissoCorporation having an office at 1411 Broadway, 35^(th) floor, New York,N.Y. Such fibers are sold under the name “Chisso ESC Bicomponent Fiber”and consist of a polypropylene core surrounded by a polyethylene sheath.Fibers that work well have a denier of about 3 and are about 38millimeters in length. Other bicomponent fibers made from polypropylene,polyethylene, etc. are commercially available from suppliers such asExxon and Dow Chemical, as well as from other vendors.

Alternatively, the non-absorbent 54 could be an absorbent material suchas a cotton/rayon blend that has been chemically treated with asurfactant to make it non-absorbent. However, materials comprised oftruly non-absorbent fibers work best.

Referring again to FIG. 3, the second surface 58 of the non-absorbent 54is shown being positioned adjacent to a cover 70. The cover 70 is anoptional element and need not be present to form the urinaryincontinence device 50. However, the cover 70 can provide a smooth outersurface that may or may not be chemically treated to facilitate acomfortable insertion and/or removal into and out of a woman's vagina.When present, the cover 70 has a length L₃ that is equal to or greaterthan the length L₂ of the non-absorbent 54. When the length L₃ of thecover 70 is longer than the length L₂ of the non-absorbent 54, it allowsthe cover 70 to overlap upon itself once the three layers 52, 54 and 70are rolled up into a cylindrical form. The extra length L₃ of the cover70 facilitates bonding of the cover 70 to itself by heat, pressure, acombination of heat and pressure, or by some other conventional meansknown to those skilled in the art. If the cover 70 is formed from amaterial that does not readily bond to itself, an adhesive, glue orother bonding or fastening medium can be used.

The cover 70 also has a width W₃ that can be less than, equal to orgreater than the width W₂ of the non-absorbent 54. Preferably, the widthW₃ of the cover 70 is approximately equal to the width W₂ of thenon-absorbent 54. This configuration allows the ends of the urinaryincontinence device 50 to be exposed. The cover 70 also has a thicknessT₃ that is less than about 0.3 inches (about 7.6 mm). Preferably, thethickness T₃ of the cover 70 should be less than about 0.2 inches (about5 mm), and most preferably, the thickness T₃ is less than about 0.1inches (about 2.5 mm).

The cover 70 can be either liquid permeable or liquid-impermeable.Preferably, the cover 70 is liquid-impermeable. By “liquid-permeable” itis meant that body fluid is able to pass through the cover 70 in a quickand efficient manner. The cover 70 can be hydrophilic, hydrophobic or acombination of each. By “hydrophilic” it is meant that the cover 70 hasan affinity for absorbing or tending to combine with water. By“hydrophobic” it is meant that the cover 70 is antagonistic to or tendsnot to combine with water. The cover 70 can also be treated with asurfactant or some other chemical to make it hydrophilic, hydrophobic orto make it more hydrophilic or more hydrophobic. Surfactants having highlubricity and hydrophobicity and which are non-irritating to the vaginalmucosa are preferred since they discourage the attraction, accumulationand retention of any resident vaginal fluid.

When the cover 70 is liquid-impermeable, it serves to block body fluidfrom contacting the non-absorbent 54. Since the non-absorbent 54 is notdesigned to absorb any body fluid, it is not necessary that the cover 70be liquid-impermeable.

Liquid permeable materials include woven and nonwoven materials having aporous substrate. Woven materials include textile fabrics that can bemade from rayon, cotton or polyolefins. The polyolefins can be eitherstaple or continuous filaments. The nonwoven materials can includespunbond, bonded-carded webs and hydroentangled webs. One material thatworks well as a cover is a 0.4 ounces per square yard (osy) spunbondpolypropylene having a crepe of at least 30 percent. Another materialthat works well as a cover is a 0.6 osy spunbond polypropylene having acrepe of at least 30 percent. Spunbond and bonded-carded webs arecommercially available from Kimberly-Clark Corporation having an officeat 401 N. Lake Street, Neenah, Wis. 54956. Another nonwoven materialthat can be used as the cover 70 is formed from 100 percent polyesterfibers held together by a binder. This material is known aspower-bonded-carded web (PBCW). PBCW is commercially available from HDKIndustries, Inc. having an office at 304 Arcadia Drive, Greenville, S.C.29609.

The cover 70 can also be constructed from a liquid-impermeable material.A good liquid-impermeable material is a micro-embossed, polymeric film,such as polyethylene or polypropylene. Bicomponent films can also beused. A preferred liquid-impermeable material is polyethylene film. Thecover 70 can further be formed from an apertured thermoplastic filmhaving either a two or three-dimensional thickness. Aperturedthermoplastic films are available from several commercial vendors. Onesuch vendor is Pantex srl, Pantex Sud srl, Via Terracini snc, having anoffice at 51031 Agliana, Pistoia, Italy. A second vendor is AppliedExtrusion Technology having a mailing address of P.O. Box 582,Middleton, Del. 19709.

The cover 70 can also be treated with an aqueous solution to reducefrictional drag, to give the urinary incontinence device 50 a permanentwettability and/or to enhance the ease of insertion into and removalfrom a woman's vagina.

Referring now to FIGS. 3-5, the resilient member 52, the non-absorbent54 and the cover 70 are rolled up or radially wound along the centrallongitudinal axis x—x into an elongated softwind 72. The non-absorbent54, shown in FIG. 3, has points A and B located at the first and secondends, 60 and 62 respectively. Preferably, the three layers 52, 54 and 70are rolled or radially wound perpendicular to the x—x axis starting atpoint A and terminating at point B. The extra length of the cover 70,located adjacent to point B and extending outward therefrom, allows thecover 70 to wrap upon itself and provides the softwind 72 with a smoothfinished appearance. The softwind 72 has a first end 74 and a second end76 and possesses a non-uniform configuration between the first andsecond ends, 74 and 76 respectively. The resilient member 52 is locatedadjacent to the second end 76 and this causes the second end 76 to havea diameter d₁ that is larger than the diameter d₂ of the first end 74.This larger diameter d₁ extends back toward the first end 74 a distanceapproximately equal to the width W₁ of the resilient member 52.

Referring to FIG. 5, the softwind 72 is then radially compressed alongthe central transverse axis y—y into an elongated pledget 78 having agenerally cylindrical configuration. The pledget 78 has an insertion end80, a trailing end 82 and a uniform cross-sectional area therebetween.The pledget 78 has a diameter d₃ that is generally smaller than thediameter d₂ of the second end 74 of the softwind 72. The diameter d₃ canrange from between about 0.2 inches (about 5 mm) to about 2 inches(about 51 mm). Preferably, the diameter d₃ of the pledget 78 will befrom about 0.5 inches (about 12.7 mm) to about 1 inch (about 25.4 mm).Most preferably, the diameter d₃ of the pledget 78 is less than about0.75 inches (about 19 mm).

A withdrawal means 84, preferably in the form of an elongated string orribbon is securely attached to the pledget 78. The withdrawal string 84facilitates the removal of the urinary incontinence device 50 from thevaginal canal 26. When the user is ready to remove the urinaryincontinence device 50, she will pull downward on the withdrawal string84. This action will cause the urinary incontinence device 50 to becomfortably withdrawn from the vaginal canal 26.

One way of securing the withdrawal string 84 to the pledget 78 is toform an aperture 86 transversely through the pledget 78 near thetrailing end 82. Preferably, the aperture 86 is spaced a short distancefrom the trailing end 82. The aperture 86 can be located a distance offrom between about 0.1 inches (about 2.5 mm) to about 0.5 inches (about12.7 mm) from the trailing end 82. Although the aperture 86 can belocated almost anywhere in the pledget 78, it preferably is locatedabout 0.25 inches (about 6.4 mm) from the trailing end 82. The aperture86 can be formed with a needle, an awl or some other type of piercingdevice known to those skilled in the art. The withdrawal string 84 isthen passed through the aperture 86. The withdrawal string 84 can belooped upon itself to form a secure attachment. The free ends of thewithdrawal string 84 are then tied in a knot 88 to assure that thewithdrawal string 84 will not separate from the urinary incontinencedevice 50. The knot 88 also serves to prevent fraying of the withdrawalstring 84 and to provide a place or point where a woman can grasp thewithdrawal string 84 when she is ready to remove the urinaryincontinence device 50 from her vagina 12. The compressed pledget 78with the withdrawal string 84 attached constitutes the finished urinaryincontinence device 50.

The withdrawal string 84 can be constructed from various types ofthreads or ribbons. A thread or ribbon made from 100 percent cottonfibers works well. The withdrawal string 84 should have a length whichextends beyond the trailing end 82 of the pledget 78 from between about2 inches (about 51 mm) to about 8 inches (about 203 mm). Preferably, thewithdrawal string 84 should have a length which extends beyond thetrailing end 82 from between about 4 inches (about 102 mm) to about 6inches (about 152 mm), and most preferably, by about 5 inches (about 127mm). The withdrawal string 84 can be dyed and/or treated with ananti-wicking agent, such as wax, before being secured to the urinaryincontinence device 50. The anti-wicking agent will reduce and hopefullyprevent body fluids from wicking along the withdrawal string 84 andcontacting the inner surface of a woman's undergarment. A dry, cleanwithdrawal string 84 is preferred by the user, especially when she goesto remove the urinary incontinence device 50 from her vagina 12.

The insertion end 80 of the urinary incontinence device 50 is designedto be the first part to enter a woman's vagina 12. When properlyinserted into the vagina 12, the entire urinary incontinence device 50will be positioned in approximately the middle third of the length ofthe vaginal canal 26. In other words, the urinary incontinence device 50occupies approximately the middle 2 inches (about 51 mm) of the vaginalcanal 26 and provides a supportive backdrop for the body tissue andmuscles located in the urethro-vaginal myofascial area 46. In thisposition, the urinary incontinence device 50 will be aligned with theupper portion of the urethra 18 and will provide a supportive backdropfor at least half of the urethra 18. During episodes of increasedintra-abdominal pressure, the compression that occurs to theurethro-vaginal myofascial area 46 between the symphysis pubis 22 andthe urinary incontinence device 50 allows the sphincter muscles 44 toacquire a more normal configuration. The sphincter muscles 44 can thenoperate properly and the urethral 8 is capable of being compressed uponitself. These two functions assist one another in alleviatinginvoluntary urine flow from the bladder 20.

The insertion end 80 of the urinary incontinence device 50 is capable ofexpanding radially outward. It is the expansion in the radial directionthat is the most important for this invention. The insertion end 80 canbe designed to radially expand outward from between about 1.2 to about10 times the initial diameter d₃ of the pledget 78. Preferably, theinsertion end 80 will be capable of radially expanding outward frombetween about 1.5 to about 4 times the initial diameter d₃ of thepledget 78. More preferably, the insertion end 80 will be capable ofradially expanding outward at least 2 times the diameter d₃ of thepledget 78. The maximum amount of radial expansion of the insertion end80 will depend on a number of factors, including the size, shape,location and composition of the resilient member 52, as well as thethickness and inherent properties of the non-absorbent 54 and the cover70. It is envisioned that one could design the urinary incontinencedevice 50 such that the insertion end 80 could radially expand more than10 times the initial diameter d₃ of the pledget 78, if desired.

The urinary incontinent device 50 will retain its generally compressedcylindrical shape until it is positioned within the vagina 12. To assistthe urinary incontinent device 50 in retaining its compressed shape, itcan be housed in an applicator or be wrapped in a thermoplastic wrapper.

It should be noted that when the urinary incontinence device 50 isproperly positioned in the vagina 12, only the withdrawal string 84 willbe exposed and extend outward from the introital opening 24.

Referring now to FIG. 6, the urinary incontinence device 50 is shownretained or housed in an applicator 90. The applicator 90 willfacilitate insertion of the urinary incontinence device 50 into awoman's vagina 12 and will assist in maintaining the uniformcross-sectional area of the pledget 78 until it is inserted into awoman's vagina. The applicator 90 can be identical to a tamponapplicator, if desired. The applicator 90 is depicted as a two-piecetelescoping applicator having a hollow outer tube 92 and a hollow innertube 94. The urinary incontinence device 50 is positioned within theouter tube 92 such that the inner tube 94, which has a smaller diameter,can be pushed against the trailing end 82. This action will cause theurinary incontinence device 50 to be expelled from the outer tube 92.The applicator 90 can be constructed of paper, cardboard or plastic. Oneexample of an applicator is taught in U.S. Pat. No. 5,795,346 whichissued to Achter et al. on Aug. 18, 1998 and is entitled: “TAMPON HAVINGA RESILIENT MEMBER.”

It should be recognized that the urinary incontinence device 50 couldalso be digitally inserted into a woman's vagina 12. For digitalinsertion, a woman would use one of her fingers to push on the trailingend 82 of the urinary incontinence device 50 so that the insertion end80 could easily enter her vagina. With digital insertion, there would beno need for an applicator.

Referring now to FIGS. 7-9, an alternative embodiment of a urinaryincontinence device 50′ is depicted. For the purpose of clarity, thenumerals recited in FIGS. 3-5 will be used for this embodiment exceptthat prime numbers will be used for new elements. The resilient member52′ is depicted as a member having a length L₄, a width W₄ and athickness T₄. The length L₄ of the resilient member 52′ is smaller thanthe length L₂ of the resilient member 52 by at least 50%. Preferably,the length L₄ of the resilient member 52′ is less than about 35% of thelength L₂ of the resilient member 52. The width W₄ of the resilientmember 52′ is greater than the width W₂ of the resilient member 52. Thewidth W₄ of the resilient member 52′ is about twice the width W₂ of theresilient member 52. The thickness T₄ of the resilient member 52′ isabout equal to the thickness T₂ of the resilient member 52.

The resilient member 52′ is positioned so as to straddle the centraltransverse axis y—y. However, it should be noted that the resilientmember 52′ could be aligned adjacent to or near either the first end 60or the second ends 62. By aligning the resilient member 52′ closer toone of the first or second ends, 60 or 62 respectively, the position ofthe resilient member 52′ in the rolled up softwind 72′ will change. Forexample, if the resilient member 52′ is placed adjacent to the first end60 and the softwind 72′ is rolled up starting from point A, theresilient member 52′ will be located next to the center of the softwind72′. This location may make it more difficult for the resilient member52′ to radially expand outward. On the other hand, if the resilientmember 52′ is placed adjacent to the second end 62 and the softwind 72′was rolled up starting again at point A, the resilient member 52′ willbe located near the outer periphery of the softwind 72′. In thisposition, the resilient member 52′ could more easily expand radiallyoutward.

Besides having a shorter length L₄ than the resilient member 52, theresilient member 52′ also differs from that shown in FIG. 3 in that ithas a greater width W₄. This increase in width W₄ will enlarge theexpansion area of the urinary incontinence device 50′. This enlargedexpansion area, denoted by W₄ in FIG. 8, is beneficial for a number ofreasons. First, the urinary incontinence device 50′ can be insertedfarther up the vaginal canal 26 while still being able to function as asupport for the urethro-vaginal myofascial area 46. Second, the enlargeddimension W₄ will contact a greater surface area of the inner periphery28 of the vaginal canal 26 and can therefore operate over a longer axialdimension. Third, by using the larger area of expansion, the urinaryincontinence device 50′ may be more comfortable for a woman to use whenproperly placed in her vagina 12.

Referring to FIGS. 8 and 9, one will notice that as the resilient member52′, the non-absorbent 54 and the cover 70, are rolled up or radiallywound along the central longitudinal axis x—x, to form a softwind 72′.The softwind 72′ has a greater area of expansion, denoted by thedimension W₄. The softwind 72′ has a first end 74′ and a second end 76′and possesses a non-uniform cross-section therebetween. The resilientmember 52′ is located adjacent to the second end 76′ of the softwind 72′and this causes the second end 76′ to have a diameter d₄ that is largerthan the diameter d₅ of the first end 74′. This larger diameter d₄extends back toward the first end 74′ a distance approximately equal tothe width W₄ of the resilient member 52′.

The softwind 72′ is then radially compressed along the centraltransverse axis y—y into an elongated pledget 78′ having a generallycylindrical configuration. The pledget 78′ has an insertion end 80′, atrailing end 82′ and a uniform cross-sectional area therebetween. Thepledget 78′ has a diameter d₆ that can range from between about 0.2inches (about 5 mm) to about 2 inches (about 51 mm). Preferably, thediameter d₆ of the pledget 78′ will be from about 0.5 inches (about 12.7mm) to about 1 inch (about 25.4 mm). Most preferably, the diameter d₆ ofthe pledget 78′ is less than about 0.75 inches (about 19 mm).

A withdrawal means 84, preferably in the form of an elongated string orribbon is securely attached to the pledget 78′. The withdrawal string 84will function as described above with reference to the first embodimentshown in FIGS. 3-6. The compressed pledget 78′ with the withdrawalstring 84 attached constitutes the finished urinary incontinence device50′.

The insertion end 80′ of the urinary incontinence device 50′ is capableof expanding radially outward. It is the expansion in the radialdirection that is the most important for this invention. Since theresilient member 52′ is smaller in size than that depicted in the firstembodiment shown in FIGS. 3-6, the amount of expansion will be less. Theinsertion end 80′ can be designed to radially expand outward frombetween about 1.1 to about 4 times the initial diameter d₆ of thepledget 78′. Preferably, the insertion end 80′ will be capable ofradially expanding outward from between about 1.3 to about 3 times theinitial diameter d₆ of the pledget 78′. More preferably, the insertionend 80′ will be capable of radially expanding outward at least 1.4 timesthe diameter d₆ of the pledget 78′. The maximum amount of radialexpansion of the insertion end 80′ will depend on a number of factors,including the size, shape, location and composition of the resilientmember 52′, as well as the thickness and inherent properties of thenon-absorbent 54 and the cover 70. It is envisioned that one coulddesign the urinary incontinence device 50′ such that the insertion end80′ could radially expand more than 2 times the initial diameter d₆ ofthe pledget 78′, if desired.

Method

The method of forming the urinary incontinence device 50 or 50′ foralleviating female urinary incontinence, especially during episodes ofincreased intra-abdominal pressure will now be explained with referenceto the flow diagrams shown in FIGS. 10 and 11. The method will bedescribed with reference to the numerals denoted in FIG. 1, simply forease of discussion, although it should be noted that the embodimentshown in FIG. 7 could also be utilized. The method includes the steps offorming a resilient member 52 into a desired geometrical shape. Theforming step can be by shaping, cutting, slitting or assembling theresilient member 52 into a predetermined configuration. A preferredshape for the resilient member 52 is an elongated strip or rectanglealthough other shapes, such as a square, an oval, an elliptical shape, aracetrack profile, etc. would work. The resilient member 52 can beformed from twisted, curled or chemically cross-linked cellulose fibersor a mixture thereof. Alternatively, the resilient member 52 can beformed from polyvinyl alcohol or from polyethylene oxide.

The resilient member 52 should have a predetermined length L₁, apredetermined width W₁, and a predetermined thickness T₁. The dimensionsof the length L₁, the width W₁, and the thickness T₁ can be varied tosuit one's desired product. The resilient member 52 has a side edge 68that is positioned on or adjacent to the side edge 64 of thenon-absorbent 54. Preferably, the side edge 68 of the resilient member52 is aligned so as to be coterminuous with the side edge 64 of thenon-absorbent 54. In addition, the resilient member 52 is positionedadjacent to, and preferably in direct contact with, the first surface 56of a non-absorbent 54 to form an assembly of two elements.Alternatively, an intermediate layer, such as one or more layers oftissue, can be placed therebetween, if desired.

The non-absorbent 54 is formed into a desired geometrical shape beforethe resilient member 52 is positioned adjacent to it. The non-absorbent54 can be formed by cutting, shaping, slitting or assembling it into thedesired configuration. A preferred configuration for the non-absorbent54 is a rectangle, although other shapes, such as a square, an oval, anelliptical shape, a racetrack profile, etc. would work. Thenon-absorbent 54 has a predetermined length L₂, a predetermined width W₂and a predetermined thickness T₂. The non-absorbent 54 has first andsecond surfaces, 56 and 58 respectively, which are spaced apart. Thenon-absorbent 54 also has a first longitudinal side edge 64 and a secondlongitudinal side edge 66. The non-absorbent 54 further has a centrallongitudinal axis x—x and a central transverse axis y—y. For bestresults, the resilient member 52 is aligned parallel to the centrallongitudinal axis x—x and is positioned such that its side edge 68 iscoterminously aligned with the first longitudinal side edge 64 of thenon-absorbent 54. The resilient member 52 can extend along the entirelength L₂ of the non-absorbent 54 or only along a portion of the lengthL₂ of the non-absorbent 54. The resilient member 52 can have a length L₁that ranges from between less than about 35% to about 100% of the lengthL₂ of the non-absorbent 54.

The resilient member 52 and the non-absorbent 54 are rolled up along thelongitudinal axis x—x into an elongated softwind 72. The softwind 72will have a first end 74, a second end 76 and a non-uniformcross-sectional area or configuration therebetween. When the side edge68 of the resilient member 52 is aligned with the longitudinal side edge64 of the non-absorbent 54, the resilient member 52 will be locatedadjacent to the second end 74 of the wound softwind 72. The softwind 72can have a diameter at one end that is at least 1.2 times greater thanthe diameter of the other end. Alternatively, the softwind 72 can have adiameter at one end that is at least 1.4 times greater than the diameterof the other end. The softwind 72 is then be compressed into a pledget78. The softwind 72 can be radially compressed to reduce itscircumference or the softwind 72 can be compressed both radially as wellas along its length. The pledget 78 has an insertion end 80, a trailingend 82 and a uniform cross-sectional area or configuration therebetween.

A withdrawal means 84, in the form of a string or ribbon, is secured tothe pledget 78 to form a urinary incontinence device 50. Preferably, thewithdrawal string 84 is securely connected to the pledget 78 approximatethe trailing end 82. One way to accomplish this is to form an aperture86 through the pledget 78 approximate the trailing end 82. Thewithdrawal string 84 is then passed through the aperture 86 and can belooped upon itself to form a secure connection. The finished urinaryincontinence device 50 can be placed in a paper or plastic applicator 90to facilitate insertion of the urinary incontinence device 50 into awoman's vagina 12. The applicator 90 can be telescopic in design usingan inner tube and an outer tube. The urinary incontinence device 50 ishoused in the outer tube and is dispensed into a woman's vagina 12 bypressing on the inner tube. As the inner tube moves into the outer tube,it causes the urinary incontinence device 50 to be expelled therefrom.

Alternatively, the urinary incontinence device 50 can be wrapped in athermoplastic film to help retain its shape until ready for use. In thisembodiment, the user would remove the wrapper and digitally insert theurinary incontinence device 50 into her vagina.

Referring again to FIGS. 3-5, it should be noted that the urinaryincontinence device 50 could contain a cover 70. The cover 70 can have alength L₃ that is greater than the length L₂ of the non-absorbent 54.The cover 70 can also be treated with a surfactant to render ithydrophobic. When a cover 70 is utilized, the resilient member 52 andthe non-absorbent 54 can be aligned and positioned on the cover 70 suchthat the non-absorbent 54 is adjacent to and preferably in directcontact with the cover 70. This means that the resilient member 52 willbe spaced apart from the cover 70. All three layers, the resilientmember 52, the non-absorbent 54 and the cover 70 can be rolled uptogether to form the elongated softwind 72. The entire softwind 72 willbe radially compressed into the pledget 78.

While the invention has been described in conjunction with two specificembodiments, it is to be understood that many alternatives,modifications and variations will be apparent to those skilled in theart in light of the aforegoing description. Accordingly, this inventionis intended to embrace all such alternatives, modifications andvariations that fall within the spirit and scope of the appended claims.

I claim:
 1. A urinary incontinence device comprising: a) a resilientmember; and b) a non-absorbent positioned adjacent to said resilientmember, said non-absorbent being constructed from a fibrous material,said non-absorbent and said resilient member being rolled into asoftwind having a first end, a second end, a first end diameter, and asecond end diameter, said resilient member being located adjacent tosaid second end, said softwind having a second end diameter larger thansaid first end diameter, said softwind being radially compressed into apledget having an initial diameter, an insertion end, a trailing end anda uniform cross-sectional area therebetween, wherein said insertion endis capable of expanding radially outward about 1.2 to about 10 timessaid initial diameter, said resilient member capable of expanding saidinsertion end of said pledget to provide a supportive backdrop for awoman's urethra when inserted into a woman's vagina.
 2. The urinaryincontinence device of claim 1 wherein said pledget has a uniformcross-sectional area extending between said insertion end and saidtrailing end, and after being positioned in a woman's vagina, saidpledget exhibits a non-uniform cross-sectional area.
 3. The urinaryincontinence device of claim 1 wherein said resilient member is a closedcell foam.
 4. The urinary incontinence device of claim 1 wherein saidresilient member is an open cell foam.
 5. The urinary incontinencedevice of claim 1 wherein said non-absorbent has a first side edge and asecond side edge and said resilient member is positioned adjacent tosaid first side edge.
 6. The urinary incontinence device of claim 5wherein said resilient member is coterminuous with said first side edgeof said non-absorbent.
 7. The urinary incontinence device of claim 1wherein said non-absorbent has a longitudinal axis and said resilientmember is aligned parallel to said longitudinal axis.
 8. The urinaryincontinence device of claim 7 wherein said non-absorbent and saidresilient member are rolled along said longitudinal axis to form saidsoftwind having a non-uniform cross-sectional area.
 9. The urinaryincontinence device of claim 8 wherein said second end diameter of saidsoftwind is at least 1.2 times said first end diameter.
 10. A urinaryincontinence device comprising: a) a resilient member; b) anon-absorbent positioned adjacent to said resilient member, saidnon-absorbent being constructed from a fibrous material, saidnon-absorbent and said resilient member being rolled into a softwindhaving a first end, a second end, a first end diameter, and a second enddiameter, said resilient member being located adjacent to said secondend, said softwind having a second end diameter larger than said firstend diameter, said softwind being radially compressed into a pledgethaving an initial diameter, an insertion end, a trailing end and auniform cross-sectional area therebetween, wherein said insertion end iscapable of expanding radially outward about 1.2 to about 10 times saidinitial diameter, said resilient member capable of expanding saidinsertion end of said pledget to provide a supportive backdrop for awoman's urethra when inserted into a woman's vagina; and c) a withdrawalstring secured to said pledget for facilitating removal of said urinaryincontinence device from a woman's vagina.
 11. The urinary incontinencedevice of claim 10 wherein an aperture is formed through said pledgetapproximate said trailing end and said withdrawal string passes throughsaid aperture.
 12. The urinary device of claim 10 wherein said secondend diameter of said softwind is at least 1.4 times greater than saidfirst end diameter.
 13. The urinary incontinence device of claim 10wherein said resilient member is formed from twisted, curled, orchemically cross-linked cellulose fibers or a mixture thereof.
 14. Theurinary incontinence device of claim 10 wherein said resilient member isformed from polyvinyl alcohol.
 15. The urinary incontinence device ofclaim 10 wherein said resilient member is formed from polyethyleneoxide.
 16. A urinary incontinence device comprising: a) a resilientmember; b) a non-absorbent positioned adjacent to said resilient member,said non-absorbent being constructed from a fibrous material, saidnon-absorbent and said resilient member being rolled into a softwindhaving a first end, a second end, a first end diameter, and a second enddiameter, said resilient member being located adjacent to said secondend, said softwind having a second end diameter larger than said firstend diameter, said softwind being radially compressed into a pledgethaving an initial diameter, an insertion end, a trailing end and auniform cross-sectional area therebetween, wherein said insertion end iscapable of expanding radially outward about 1.2 to about 10 times saidinitial diameter, said resilient member capable of expanding saidinsertion end of said pledget to provide a supportive backdrop for awoman's urethra when inserted into a woman's vagina; c) a cover at leastpartially enclosing said pledget; and d) a withdrawal string secured tosaid pledget for facilitating removal of said urinary incontinencedevice from a woman's vagina.
 17. The urinary incontinence device ofclaim 16 wherein said cover is positioned adjacent to said non-absorbentand is located away from said resilient member.
 18. The urinaryincontinence device of claim 17 wherein said non-absorbent has apredetermined length and said cover has a length greater than the lengthof said non-absorbent.
 19. The urinary incontinence device of claim 16wherein said second end diameter of said softwind is at least 1.4 timessaid first end diameter.
 20. The urinary incontinence device of claim 16wherein said cover is treated with a surfactant to render ithydrophobic.